MOSAIC® 310C27 (UDI 00643169594845)Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00643169594845), received between May 24, 2017 and Sep 23, 2026 — classified as 9 deaths, 61 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (38 reports).

3 other recalls cover devices cleared under the same FDA submission (P990064); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• DeathSep 23, 2026Insufficient Device Problem Information

  It was reported that during the implant of this 27mm mitral bioprosthetic valve, it was explanted and replaced with a new 27mm mitra l bioprosthetic valve of the same model or vice versa. The reason for the replacement was not reported. It was further reported that on the same day the patient was reported deceased. It was noted that the mitral device which remained implanted in the patient was unconfirmed. The cause of death was not received. Therefore, relatedness of the death to the valves could not be excluded. It is unknown whether an autopsy was performed.

  Patient problems: Insufficient Information

  MAUDE report 50866012 ↗
• DeathAug 26, 2026Insufficient Device Problem Information

  It was reported that 2 days post implant 29mm mitral bioprosthetic valve and 27mm mitral bioprosthetic valve, the patient died. It was noted that during the mitral valve replacement procedure on (b)(6) 2026, the mitral valve which was explanted during the procedure could not be confirmed. The cause of death was not received. Therefore, relatedness of the death to the valve could not be excluded. It is unknown whether an autopsy was performed.

  Patient problems: Insufficient Information

  MAUDE report 50454464 ↗
• InjuryJun 16, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 12 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25520258 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH A NEW 27MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25056374 ↗
• MalfunctionApr 29, 2026Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS 27MM MOSAIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE CINCH DEVICE WAS OVER-CINCHED AND THE VALVE DID NOT WORK AS DESIGNED. THE DEVICE WAS NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031582 ↗
• InjuryApr 29, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE AND 27MM MITRAL BIOPROSTHETIC VALVE A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25026571 ↗
• InjuryJan 8, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID HAVE PRE-EXISTING ARRHYTHMIAS PRIOR TO THIS TVR, THE PATIENT HAD JUNCTIONAL BRADYCARDIA AND HAD PPM PLACED PRIOR TO SURGERY. THE TVR DID NOT CAUSE OR CONTRIBUTE TO THE CONDUCTION DISTURBANCE. THE REPLACEMENT OF PPM WAS PLANNED TO HAPPEN CONCOMITANT TO TVR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Heart Block

  MAUDE report 24002901 ↗
• InjuryJan 7, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 1 YEAR AND 7 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE REGUR GITATION. IT WAS REPORTED THAT AN INTERVENTION WAS SCHEDULED FOR (B)(6) 2026. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23987802 ↗
• InjuryNov 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT BI-VENTRICULAR PACEMAKER WAS IMPLANTED ON THE SAME DAY. THE REASON FOR PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 23665278 ↗
• InjurySep 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS MOSAIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS) AND AV BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23083703 ↗
• InjuryAug 13, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR INTERVENTION AS INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22797135 ↗
• InjuryJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT REMOVAL OF AN OLD TISSUE VALVE AND IMPLANTATION OF A NEW TISSUE VALVE IN THE PULMONARY POSITION. THE PATIENT INITIALLY RECEIVED A 27MM MITRAL BIOPROSTHETIC TISSUE VALVE IMPLANTED IN THE PULMONARY POSITION ON (B)(6) 2020, FOLLOWED BY A NEW TISSUE VALVE IMPLANT IN THE SAME POSITION ON (B)(6) 2025.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22465230 ↗
• InjuryMar 7, 2025Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem; Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 27MM MOSAIC MITRAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Insufficient Information; Obstruction/Occlusion

  MAUDE report 21545545 ↗
• InjuryJan 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 4 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT A AORTIC VALVE REPLACEMENT (AVR) WAS ALSO PERFORMED DURING THE SAME PROCEDURE FOR SEVERE AORTIC STENOSIS (AS) AND AORTIC REGURGITATION (AR). A 21MM MOSAIC AORTIC VALVE WAS IMPLANTED DURING THE PROCEDURE. IT WAS INDICATED THAT THE PATIENT HAD SEVERE LEFT VENTRICLE DYSFUNCTION AND REQUIRED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND IMPELLA SUPPORT POST OPERATIVELY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21157023 ↗
• InjuryOct 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT AN ELECTROCARDIOGRAM (ECG) HAD REVEALED BRADYCARDIA OF UNCLEAR ETIOLOGY. IT WAS STATED THAT THE PATIENT HAD A SYNCOPAL EPISODE AND HAD BEEN EXPERIENCING LIGHTHEADEDNESS. A BETA BLOCKER MEDICATION WAS STOPPED. IT WAS ALSO REPORTED THAT THE PATIENT HAD ATRIAL FIBRILLATION (AFIB) AND ATRIAL FLUTTER AND WAS TAKING AN ANTICOAGULANT MEDICATION. SICK SINUS SYNDROME (SSS) WAS ALSO REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Bradycardia; Cardiac Arrest; Dizziness; Insufficient Information; Non specific EKG/ECG Changes; Syncope/Fainting

  MAUDE report 20495801 ↗
• InjuryJun 14, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS INCORRECT SIZING ERROR. IT WAS STATED THAT MEDTRONIC SIZERS WERE USED FOR VALVE SIZING AND THE REPLICA END OF THE SIZER WAS USED TO SELECT THE VALVE SIZE. IT WAS REPORTED THAT THE VALVE WAS INSPECTED PRIOR TO USE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19538009 ↗
• InjuryMay 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS BRADY/TACHY SYNDROME, ATRIAL FIBRILLATION, ATRIAL TACHYCARDIA AND ATRIAL FLUTTER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Bradycardia; Tachycardia

  MAUDE report 19284701 ↗
• InjuryMar 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 3RD DEGREE ATRIO-VENTRICULAR BLOCK (AVB) OR COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 18995150 ↗
• InjuryFeb 23, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, THE PRESENCE OF ATRIAL FLUTTER WAS SUSPECTED. AN ANTIARRHYTHMIC AND ANTICOAGULANT WAS ADMINISTERED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18768363 ↗
• InjuryJan 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 9 DAYS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, A CARDIAC DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE CARDIAC DEFIBRILLATOR WAS REPORTED AS LONG QT SYNDROME (LQTS), HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY (HOCM) AND BRUGADA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18552802 ↗
• InjuryDec 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18318076 ↗
• InjuryDec 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR THE REPLACEMENT WAS REPORTED AS CONFIRMED BACTERIAL ENDOCARDITIS WITH VEGETATION ON THE MITRAL VALVE ANNULUS AND SUB VALVULAR APPARATUS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 18262724 ↗
• InjuryNov 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PATIENT WENT INTO CARDIAC ARREST DUE TO A HEROIN OVERDOSE. IT WAS ALSO REPORTED THAT THE PATIENT HAD A WEAK AND THREADY PULSE FOLLOWED BY NO PULSE AND SEIZURE LIKE ACTIVITY WITH CYANOTIC APPEARANCE. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED 5 MINUTES OF CARDIOPULMONARY RESUSCITATION (CPR) AND A SHOCK BY THE AUTOMATED EXTERNAL DEFIBRILLATOR (AED). THE PATIENT WAS ADDITIONALLY GIVEN 16MG OF NARCAN AND SUCCESSFULLY RESUSCITATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole; Cardiac Arrest

  MAUDE report 18160014 ↗
• InjuryNov 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETED HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WEREREPORTED.

  Patient problems: Heart Block

  MAUDE report 18109528 ↗
• InjuryOct 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT AFTER AN UNKNOWN DURATION POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 17964912 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990064. One submission often covers many models, so check the product and lot details in each record.

• Z-1880-2019 · May 21, 2019 · Terminated
  Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
• Z-1881-2019 · May 21, 2019 · Terminated
  Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
• Z-1225-2009 · Jan 26, 2009 · Terminated
  Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C21AA, 305C2701, 305C2301, 305C2501, and 305C2901; Sterile LC; Rx only; Medtronic Inc 710 M